BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRE STAR RX PTCA BALLOON CATHETER

    MDR report key: 1884941 · Received October 28, 2010

    Report

    Report Number
    9616099-2010-00823
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 26, 2010
    Report Date
    October 10, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P880003/S90
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00823 AND 9616099-2010-00824. INFORMATION RECEIVED FROM A SALES REPRESENTATIVE INDICATED THAT INFLATION AND DEFLATION DIFFICULTY WAS ENCOUNTERED WITH TWO FIRESTAR BALLOONS. THE PHYSICIAN USED A 2.5 X 20 MM FIRESTAR BALLOON CATHETER TO PRE-DILATE A 95% LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE BALLOON INFLATED VERY SLOWLY, AND WHEN THE PHYSICIAN DEFLATED IT, IT ALSO DEFLATED VERY SLOWLY. THEREFORE, THE PHYSICIAN WITHDREW THE BALLOON AND CHANGED TO ANOTHER 2.5 X 20 MM FIRESTAR BALLOON CATHETER. HOWEVER, THIS BALLOON CATHETER ALSO INFLATED VERY SLOWLY. WHEN THE PHYSICIAN TRIED TO DEFLATE THE BALLOON IT WOULD NOT DEFLATE. THE PHYSICIAN HAD TO WITHDRAW THE BALLOON CATHETER AND THE GUIDING CATHETER FROM THE PATIENT TOGETHER. THE PHYSICIAN THEN CHANGED TO ANOTHER COMPANY'S BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO DIFFICULTY IN REMOVING THE DEVICES FROM THE PROTECTIVE HOOPS, REMOVING THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS NOTED ON THE DEVICES AND THEY PREPPED NORMALLY. THE BRAND OF CONTRAST WAS GE IN A 1:1 RATIO. THE INDEFLATOR WAS MADE BY MERIT AND WAS SUCCESSFULLY USED WITH ANOTHER BALLOON. THERE WAS NO DIFFICULTY ADVANCING TO OR CROSSING THE LESION WITH EITHER BALLOON. THE DEVICE WAS NOT IN AN ACUTE BEND AND THERE WAS NO LEAKAGE NOTED ON THE DEVICE. THE MAXIMUM INFLATION PRESSURE WAS 14 ATMS AND THE BALLOON DEFLATED IN 20 SECONDS. THERE WAS NO REPORT OF PATIENT INJURY AND THE DEVICES WERE RETURNED FOR EVALUATION. ONE NON STERILE FIRE STAR 2.50 X 20 PTCA BALLOON CATHETER WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE OUTER BODY WAS COMPRESSED AT THE DISTAL AREA; THIS CONDITION ON THE OUTER BODY COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR THE ANALYSIS. RESIDUES OF CRYSTALLIZED INFLATION MEDIA WAS OBSERVED IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS RECEIVED ALREADY INFLATED AND DEFLATED. AN ATTEMPT TO INFLATE THE BALLOON WAS PERFORMED; HOWEVER IT COULD NOT BE INFLATED DUE TO THE RESIDUES OF CRYSTALLIZED INFLATION MEDIUM. AFTER THE RESIDUES WERE REMOVED THE BALLOON WAS INFLATED AND DEFLATED WITHIN SPECIFICATION TIME. SEM ANALYSIS RESULTS: BOTH THE TRANSITION SEAL AND THE PROXIMAL SEAL PRESENTED NO EVIDENCE OF BLOCKAGE OR ANY OTHER ANOMALY THAT COULD BE RELATED TO THE REPORTED FAILURE. THE SAMPLE EXHIBITED NO EVIDENCE OF INTERNAL OR EXTERNAL SURFACE MATERIAL DAMAGE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE CUSTOMER REPORTED COMPLAINT OF INFLATION AND DEFLATION DIFFICULTY WAS NOT CONFIRMED SINCE ONCE THE CONTRAST RESIDUE WAS REMOVED FROM THE DEVICES THEY WERE ABLE TO INFLATE AND DEFLATE WITHIN THE SPECIFICATION TIME FRAME. THE EXACT CAUSE FOR THE DIFFICULTIES ENCOUNTERED BY THE CUSTOMER COULD NOT BE DETERMINED, HOWEVER SINCE THE DEVICES PERFORMED TO SPECIFICATION THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    GE CONTRAST WAS USED DURING THE INDEX PROCEDURE AND A MERIT INDEFLATOR WAS ALSO USED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00823 AND 9616099-2010-00824. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PHYSICIAN USED A 2.5 X 20MM FIRESTAR BALLOON CATHETER TO PRE-DILATE A 95% LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE BALLOON INFLATED VERY SLOW, AND WHEN THE PHYSICIAN DEFLATED IT, IT ALSO DEFLATED VERY SLOW. THEREFORE, THE PHYSICIAN WITHDREW THE BALLOON AND CHANGED TO ANOTHER 2.5 X 20MM FIRESTAR BALLOON CATHETER. HOWEVER, THIS BALLOON CATHETER ALSO INFLATED VERY SLOWLY. WHEN THE PHYSICIAN TRIED TO DEFLATE THE BALLOON IT WOULD NOT DEFLATE. THE PHYSICIAN HAS TO WITHDRAW THE BALLOON CATHETER AND THE GUIDING CATHETER FROM THE PATIENT TOGETHER. THE PHYSICIAN THEN CHANGED TO ANOTHER COMPANY'S BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRE STAR RX PTCA BALLOON CATHETER PTCA BALLOON CATHETERS (LOX) LOX CORDIS DE MEXICO NA 15029933

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR